Evidence map›Paper›PMID 42120573›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2026

Comparison of tuboplasty and tympanotomy tube, alone or in combination for the treatment of chronic otitis media with effusion: randomized controlled trial.

Zihan Lou, Zhengcai Lou, Yuan Yu, Jiaming Ji, Jingjing Wang, Boya Zhang, Yibing Hu, Yihuan Zhang, Zhengnong Chen

Abstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Zihan LouDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.ORCID http://orcid.org/0000-0001-8922-6054
Zhengcai LouDepartment of Otorhinolaryngology, Yiwu Central Hospital, 699 Jiangdong Road, Yiwu City, 322000, Zhejiang Province, China.
Yuan YuDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. yuyuan0320@sjtu.edu.cn.
Jiaming JiDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Jingjing WangDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Boya ZhangDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Yibing HuDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Yihuan ZhangDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Zhengnong ChenDepartment of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. jassey@126.com.ORCID http://orcid.org/0000-0001-7774-441X

Funding

National Key Research and Development Program of China 2023YFC2508404
6 · The paper itself

Abstract

objectiveThe objective of this study was to compare the tympanotomy tube (TT) retention success rates, the chronic otitis media with effusion (COME) recurrence rates, and the complications of radiofrequency tuboplasty only (RT-only), tympanotomy tube insertion (TTI) + RT, and TTI-only, used to treat unilateral chronic otitis media with effusion (COME) in adult associated with hypertrophy of the nasopharyngeal orifice of the Eustachian tube. MATERIALS AND

methodsPatients with COME and hypertrophy of the nasopharyngeal orifice were randomly allocated to either an RT-only group or a TTI + RT group or a TTI-only group. The successful treatment rates, TT retention rates, OME recurrence rates, postoperative Eustachian tube (ET) orifice mucosal inflammation (ETI) grades, and complications were evaluated 18 months after surgery.

resultsA total of 156 COME patients were included. The successful treatment rates differed significantly among the three groups (P < 0.01). The TT retention success rate in the TTI + RT group was significantly higher than in the TTI-only group (96.2% vs. 82.7%, P < 0.05). The total TT premature extrusion rates at 6-12 months differed significantly between the TTI + RT and TTI-only groups (P < 0.05). Similarly, the total OME recurrence rates differed significantly among the three groups (P < 0.001). At both 6-12 and 12-18 months, the differences were significant between the TTI-only, and the RT-only and TTI + RT groups (P < 0.05). In the RT-only and TTI + RT groups, the OME recurrence rates of patients with preoperative grade 3 ETI were significantly higher than those of patients with preoperative grade 4 ETI. No RT-related severe adverse event was observed in the RT-only or TTI + RT group. Only three patients developed small red granulomas in the posterior cushion.

conclusionsThe TTI + RT group exhibited the highest treatment success rate and the most durable outcomes of selected COME patients with hyperplastic ET nasopharyngeal orifices. However, given the small sample size, the short follow-up time, and the co-interventions, future studies with larger cohorts are required to validate the findings. In addition, it is important to explore further whether RT more effectively treats hypertrophic mucosa than hypertrophic cartilage at the nasopharyngeal orifice.

Indexed as

Eustachian TubeMiddle Ear VentilationOtitis Media with EffusionAdultAgedChronic DiseaseCombined Modality TherapyFemaleHumansHypertrophyMaleMiddle AgedNasopharynxRecurrenceTreatment OutcomeEustachian tube dysfunctionNasopharyngeal orificeOtitis media with effusionTuboplastyTympanotomy tube

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.